← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
NQQ — System, Imaging, Optical Coherence Tomography (Oct)
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
DEVICE CLASS
Class II
REGULATION
21 CFR 892.1560
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES
Recent clearances
K253459ABBOTT MEDICAL · 510k2026-04-24
K251730Leadoptik, Inc. · 510k2025-12-19
K253101Spectrawave, Inc. · 510k2025-12-15
K252851Damae Medical · 510k2025-10-07
K251198Spectrawave, Inc. · 510k2025-07-16
K250684Terumo Cardiovascular Systems Thi Plant · 510k2025-07-02
K242924Opxion Technology, Inc. · 510k2025-06-23
K242098Shenzhen Vivolight Medical Device & Technology Co., Ltd. · 510k2025-04-11
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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